Interferon patterns in cancer patients receiving CTLA-4 or PD-1/PD-L1 inhibitors versus autoimmune disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study will enroll about 300 adults with cancer who are ICI‑naïve and about 40 adults with classified systemic autoimmune diseases to compare blood interferon (IFN) signatures. Small blood samples will be collected at predefined time points around initiation of anti‑CTLA‑4 and/or anti‑PD‑1/PD‑L1 therapy to measure IFN‑related biomarkers. Investigators will compare IFN patterns in cancer patients who do and do not develop immune‑related adverse events (irAEs) and contrast those patterns with IFN profiles from patients with lupus, Sjögren's, systemic sclerosis, or inflammatory myopathies. Patients on concurrent chemotherapy, tyrosine kinase inhibitors, high‑dose steroids, or with severe active autoimmune disease are excluded to isolate ICI effects.

Why it matters

Who can join: the full rules

ICI cohort:

Inclusion Criteria:

* Initiation of treatment with a single ICI or dual ICI therapy in accordance with current clinical guidelines;
* Patients who are treatment-naïve to ICIs; and
* Age ≥18 years.

Exclusion Criteria:

* Estimated mortality of less than 3 months from the start of treatment;
* Current combination therapy with chemotherapy, tyrosine kinase inhibitors, or other tumor-specific treatments;
* Contraindication to treatment with ICIs (documented hypersensitivity, severe active autoimmune disease, Eastern Cooperative Oncology Group \[ECOG\] ≥3);
* Ongoing immunosuppressive therapy, including prednisone at doses \>10 mg/day or equivalent.

SAD cohort:

Inclusion Criteria:

* Meeting classification criteria for Systemic Lupus Erythematosus (SLE) (ACR/EULAR 2019), Primary Sjögren's Syndrome (pSS) (ACR/EULAR 2016), Systemic Sclerosis (SSc) (ACR/EULAR 2013), and/or Idiopathic Inflammatory Myopathy (IIM) (ACR/EULAR 2017).
* Age ≥18 years old.

Exclusion Criteria:

* Estimated mortality less than 3 months from the start of follow-up.
* Active immunosuppressive treatment, including prednisone at doses \>10 mg/day or equivalent.
* Recent diagnosis (\<1 year) of cancer, with the exception of non-melanoma skin cancer, or currently receiving active oncology-specific treatment.

Where it's running

• Hospital Universitario de Navarra
  Pamplona, Navarre, Spain Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Universal CD19-targeting CAR-γδT cell therapy for refractory autoimmune diseases

  This trial will try infusing universal CD19-targeting CAR-γδT cells into adults with refractory B cell–driven autoimmune diseases to see if removing autoreactive B cells improves symptoms.

  Recruiting Phase 1/2 Peking University Third Hospital · Beijing · NCT06828042

• BCT301 CAR-iT cell therapy for hard-to-treat autoimmune diseases

  This early‑phase study tests whether off-the-shelf BCT301 CAR-iT cells can be given safely to adults with refractory autoimmune diseases to see if they can be tolerated and what dose works best.

  Recruiting Early Phase 1 Peking University Third Hospital · Beijing · NCT07301164

• AlloNK® therapy combined with rituximab for treating certain autoimmune diseases

  This study is testing if a new treatment called AlloNK® combined with rituximab can help people with tough-to-treat autoimmune diseases feel better.

  Recruiting at 52 sites Phase 2 Artiva Biotherapeutics, Inc. · Tuscaloosa, Alabama and 51 other locations · NCT06991114

• BCMA-CD19 CAR-T therapy for autoimmune diseases

  This study is testing a new CAR-T cell therapy to see if it can help adults with tough autoimmune diseases feel better and improve their health.

  Recruiting Phase 2 Peking University People's Hospital · Beijing, Beijing Municipality · NCT06794008

• BA1203 in advanced solid tumors: safety and early signs of activity

  This early-phase trial tests BA1203 in adults with advanced solid tumors to see if it is safe, tolerable, how the drug behaves in the body, and whether it shows any early signs of effectiveness.

  Recruiting Phase 1 Shandong Boan Biotechnology Co., Ltd · Beijing · NCT07876609

• Progressive Muscle Relaxation for Fatigue and Breathing in Systemic Sclerosis

  Aims to see if progressive muscle relaxation can help reduce fatigue and breathing difficulties and improve lung function in adults with systemic sclerosis.

  Recruiting University of Gaziantep · Gaziantep, Şehitkamil · NCT07842133

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.